FDA Adverse Event
Injury
Summary report: N
ATTAIN CS
MDR report key: 4161337
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11558
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- July 2, 2014
- Report Date
- July 2, 2014
- Manufacturer
- MPRI
- Product Code
- LWP
- PMA / PMN Number
- P010015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: A 8042B IPG, IMPLANTED: (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS, INTERMITTENT CAPTURE AND HIGH IMPEDANCE WITH POSSIBLE FRACTURE. THE LV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 642178 | ATTAIN CS | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MPRI | 2188-75 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| R | 5076-52 LEAD, 5076-45 LEAD |